Roche gains FDA breakthrough status for Tecentriq combination

Roche has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for the combination of Tecentriq (atezolizumab) with Avastin (bevacizumab) to treat hepatocellular carcinoma (HCC), the most common form of liver cancer.

The combination is indicated as a first-line treatment for advanced or metastatic HCC patients.

Tecentriq is a monoclonal antibody being developed to bind with programmed cell death-ligand 1 (PD-L1) expressed on tumour and tumour-infiltrating immune cells for preventing interactions with PD-1 and B7.1 receptors.

Avastin is a biologic antibody that selectively binds to the Vascular endothelial growth factor protein associated with development and maintenance of tumour blood vessels, and interrupts the blood supply.

The combination of these drugs is expected to improve the immune system’s potential to address various cancer types.

Roche chief medical officer and Global Product Development head Sandra Horning said: “Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide.

“Preliminary data from the combination of Tecentriq and Avastin in this disease are promising and we look forward to working with health authorities to make this potential treatment regimen available to people with hepatocellular carcinoma as soon as possible.”

The FDA decision comes after a review of data from a Phase Ib clinical trial that evaluated the safety and clinical activity of the Tecentriq and Avastin combination in patients suffering from advanced, unresectable or metastatic first-line HCC.

The primary objective of the multi-centre trial is clinical activity assessment, while the secondary efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DOR) and time to progression (TTP).

Findings demonstrated responses in 15 out of the total 23 efficacy-evaluable patients, which represents 65%, following a median follow-up of 10.3 months. The trial is yet to reach the PFS, DOR, TTP and OS endpoints.

The evaluation did not find any new safety issues from the individual profiles that are currently established for the two medicines.